Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021411
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | No | No |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/29/2026 | SUPPL-53 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021411s053lbl.pdf | |
| 06/29/2026 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021411s053lbl.pdf | |
| 01/06/2022 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021411s050lbl.pdf | |
| 02/25/2020 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021411s049lbl.pdf | |
| 05/19/2017 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021411s048lbl.pdf | |
| 05/26/2015 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s046lbl.pdf | |
| 04/17/2015 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s047lbl.pdf | |
| 02/20/2014 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021411s044lbl.pdf | |
| 12/04/2013 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s045lbl.pdf | |
| 08/05/2013 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s042lbl.pdf | |
| 08/05/2013 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s040lbl.pdf | |
| 08/16/2012 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s036lbl.pdf | |
| 07/05/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s034lbl.pdf | |
| 06/14/2012 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s039lbl.pdf | |
| 03/07/2011 | SUPPL-35 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021411s035lbl.pdf | |
| 03/07/2011 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021411s035lbl.pdf | |
| 07/29/2010 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021411s032lbl.pdf | |
| 06/03/2009 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021411s029s030lbl.pdf | |
| 06/03/2009 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021411s029s030lbl.pdf | |
| 07/23/2008 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf | |
| 07/23/2008 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf | |
| 07/23/2008 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf | |
| 09/28/2007 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s019lbl.pdf | |
| 04/25/2007 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf | |
| 04/25/2007 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf | |
| 04/25/2007 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf | |
| 04/25/2007 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf | |
| 04/25/2007 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf | |
| 10/19/2006 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021411s018lbl.pdf | |
| 01/17/2003 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21411slr001_strattera_lbl.pdf | |
| 11/26/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021411s000lbl.pdf |